MAUDE Adverse Event Report: UNOMEDICAL A/S MIO; INSET LL

Model Number MMT-943

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hypoglycemia (1912)

Event Date 09/09/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).No further information available at this time, unomedical is investigating further information.A follow-up will be submitted no later than 07/05/2018.

Event Description

(b)(4).(b)(6).Patient deceased saturday (b)(6) 2017 in (b)(6), probably for hypoglycemia event.No further information available at this time, unomedical is investigating further information.

Manufacturer Narrative

No relevant testing could be performed.If lot information was available, the batch records and the complaint database were reviewed for relevant deviations and similar complaints.  the claimed failure cannot be confirmed.The complaint has been reviewed based on the customer complaint description and evaluates that no further investigation can be performed before either used samples are received for testing or that the lot number is provided to investigate a potential origin of the product failure in the devices manufacturing traceability documents.

Event Description

(b)(4).(b)(6).Patient deceased saturday (b)(6) 2017 in (b)(6), probably for hypoglycemia event.No further information available.

• Brand Name: MIO
• Type of Device: INSET LL
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aalholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 7577023
• MDR Text Key: 110323997
• Report Number: 3003442380-2018-00022
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MMT-943
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death